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Immunogenicity and Safety According to Immunosuppressive Drugs and Different COVID-19 Vaccine Platforms in Immune-Mediated Disease: Data from SAFER Cohort

2024; Multidisciplinary Digital Publishing Institute; Volume: 12; Issue: 12 Linguagem: Inglês

10.3390/vaccines12121367

2076-393X

Ketty Lysie Libardi Lira Machado, Ana Paula Neves Burian, Olindo Assis Martins‐Filho, José Geraldo Mill, Lunara Baptista Ferreira, K. Rosemarie Lallemand Tapia, Anna Carolina Simões Moulin, Isac Ribeiro Moulaz, Priscila Dias Cardoso Ribeiro, Vanessa de Oliveira Magalhães, Erika Biegelmeyer, Flávia Maria Matos Melo Campos Peixoto, Sandra Lúcia Euzébio Ribeiro, Camila Maria Paiva França Telles, Juliana Bühring, Natália Sarzi Sartori, Vanessa Hax, Rodrigo Poubel Vieira de Rezende, Kátia Lino, Ana Karla Guedes de Melo, Vítor Alves Cruz, Rejane Maria Rodrigues de Abreu Vieira, Renata Henriques de Azevedo, Valdeŕilio Feijó Azevedo, Marcelo M. Pinheiro, Odirlei André Monticielo, Edgard Torres dos Reis Neto, Andréa Teixeira−Carvalho, Ricardo Machado Xavier, Emília Inoue Sato, Viviane Angelina de Souza, Gilda Aparecida Ferreira, Gecilmara Salviato Pileggi, Valéria Valim,

COVID-19 Clinical Research Studies

Background/Objectives: The effectiveness of COVID-19 vaccine in patients with immune-mediated inflammatory diseases (IMID) depends on the underlying disease, immunosuppression degree and the vaccine regimens. We evaluate the safety and immunogenicity of different COVID-19 vaccine schedules. Methods: The SAFER study: “Safety and effectiveness of the COVID-19 Vaccine in Rheumatic Disease”, is a Brazilian multicentric prospective observational phase IV study in the real-life. Data were analyzed after 2 or 3 doses of COVID-19 vaccines: adenoviral vectored vaccine (ChAdOx1 nCoV-19, Astrazeneca), mRNA vaccine (BNT162b2, Pfizer–BioNTech) or inactivated SARS-COV-2 vaccine (CoronaVac, Sinovac Biotech). IgG antibody against SARS-CoV-2 spike (IgG-S) receptor-binding domain level were quantified at baseline (T1) and 28 days after the first (T2), 2nd (T3) and 3rd (T4) doses by chemiluminescence (SARS-CoV-2-IgG-II Quant-assay, Abbott-Laboratories). Results: 721 patients with IMID were included in the analysis. The median titers of IgG-S (BAU/mL) increased progressively over the times: at baseline was 6.26 (5.41–7.24), T2: 73.01 (61.53–86.62), T3: 200.0 (174.36–229.41) and T4: 904.92 (800.49–1022.97). The multivariate linear regression showed that greater IgG-S titers were associated with pre-exposure to COVID-19 (p < 0.001) and BNT162b2 booster vaccine (p < 0.001). Rituximab and immunosuppressant drugs were independent factors for low titers (p = 0.002, p < 0.001, respectively). No serious adverse event was reported. Conclusions: All platforms were safe and induced an increase in IgG-S antibodies. COVID-19 pre-exposure and BNT162b2 booster regimens were predictors of higher humoral immune responses, which is relevant in immunosuppressed populations. Immunosuppressants (mainly rituximab) predicted the lowest antibodies.